FDA Inspection 1027634 — Biokosmes Srl
The FDA completed an inspection of Biokosmes Srl on September 22, 2017 in Bosisio Parini. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bosisio Parini (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |